Journal Pre-proof

Implementation of Nagoya Protocol on Access and benefit-sharing in Peru:

Implications for researchers

Fabio Friso, Fernando Mendive, Marco Soffiato, Valerio Bombardelli, Alan Hesketh,
Michael Heinrich, Luigi Menghini, Matteo Politi
PII: S0378-8741(20)30534-1
DOI: https://doi.org/10.1016/j.jep.2020.112885
Reference: JEP 112885

To appear in: Journal of Ethnopharmacology

Received Date: 5 February 2020

Revised Date: 10 April 2020
Accepted Date: 13 April 2020

Please cite this article as: Friso, F., Mendive, F., Soffiato, M., Bombardelli, V., Hesketh, A., Heinrich,
M., Menghini, L., Politi, M., Implementation of Nagoya Protocol on Access and benefit-sharing in
Peru: Implications for researchers, Journal of Ethnopharmacology (2020), doi: https://doi.org/10.1016/
j.jep.2020.112885.

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Title. Implementation of Nagoya Protocol on Access and Benefit-Sharing in Peru: Implications for

researchers

Authors. Fabio Frisoa; Fernando Mendivea; Marco Soffiatoa; Valerio Bombardellib; Alan Heskethc;

Michael Heinrichd; Luigi Menghinie; Matteo Politia,e*

a
Center for Drug Addiction Treatment and Research on Traditional Medicines - Takiwasi, Prolongación

Alerta 466, Tarapoto, Peru

b
Legal department and Agreements, Indena S.p.A., Viale Ortles 12, Milan, Italy
c
Indigena Biodiversity Limited, 8 South Park Court, South Park, Gerrards Cross, Bucks, England
d
UCL School of Pharmacy, 29-39 Brunswick Square, London, England
e
Department of Pharmacy, University of Chieti-Pescara, Via Vestini 31, Chieti Scalo, Italy.

*
Corresponding author. Center for Drug Addiction Treatment and Research on Traditional Medicines -

Takiwasi, Prolongación Alerta 466, Tarapoto, Peru. E-mail address: matteo.politi@takiwasi.com

Abstract

Ethnopharmacological relevance: The Peruvian Amazon holds more than 1000 plant species with

commercial potential and the national sales of natural products derived from medicinal and aromatic

plants have exceeded $ 400 million per year. Research and development activities carried out on the

genetic and biochemical composition of Peruvian flora have to abide by national and international

regulations, such as the Nagoya Protocol (NP).

1
Aim of the study: The aim of this paper is to describe the implications of the current implementation of the

NP in Peru for performing research on national genetic resources.

Materials and methods: A review of the current legal framework and status of the NP in Peru was

performed accompanied by first-hand experience undertaken by submitting a request for access to genetic

resources related to wild continental species.

Results: So far, Peru has issued only 6 Internationally Recognized Certificates of Compliance (IRCCs)

through 2 of the identified National Authorities. Some of the difficulties and challenges observed have to

do with the degree of effective implementation of the Access and Benefit-Sharing (ABS) system, the fact

that the application process is not sufficiently clear, and the wide gap between this formal system and

what occurs informally outside of it. In response to this, training and implementation projects have been

launched and a new law on the access to genetic resources has been proposed.

Conclusions: The difficulties observed represent an obstacle to scientific research and the development of

new commercial products based on Peruvian traditional knowledge and genetic resources. The ineffective

application of the NP in Peru could also lead interested parties to move their activities to neighbouring

countries.

Keywords

Nagoya Protocol; Access and Benefit-Sharing; Collective Knowledge; Intellectual Property; Biotrade;

Glossary

ABS - Access and Benefit-Sharing

ABSCH - Access and Benefit-Sharing Clearing-House

CAN - Competent National Authority

CBD - Convention on Biological Diversity

2
CNBio - National Commission Against Biopiracy

CONADIB - National Commission of Biological Diversity

CONCYTEC – National Council of Science, Technology and Technological Innovation

DIGEMID - Directorate General of Medicines, Supplies and Drugs

DIGESA - General Directorate of Environmental Health

DIN - Directorate of Inventions and New Technologies

GEF - Global Environmental Facility

INDECOPI - National Institute for the Defence of Free Competition and the Protection of Intellectual

Property

INIA - National Institute of Agricultural Innovation

IRCC - Internationally Recognized Certificate of Compliance

MAT - Mutually Agreed Terms

MINAM - Ministry of Environment

NFP - National Focal Point

NP - Nagoya Protocol

PIC - Prior Informed Consent

PRODUCE - Ministry of Production

SERFOR - National Forest and Wildlife Service

SIPO - State Intellectual Property Office

TK - Traditional Knowledge

WIPO - World Intellectual Property Organization

IGC - Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional

Knowledge and Folklore

3
1. Introduction

1.1 From the Convention on Biological Diversity to Nagoya Protocol

The Convention on Biological Diversity (CBD or Rio Convention from Rio de Janeiro, Brazil) was the

first international treaty in 1992 to deal with ownership of genetic resources (Hesketh, 2015). Its three

objectives are: the conservation of biological diversity; the sustainable use of its components; the fair and

equitable sharing of the benefits arising from the utilization of genetic resources (CBD, 1992). The CBD

was later reinforced by the Nagoya Protocol (NP), adopted on 29 October 2010 in Nagoya, Japan, and

entered into force on 12 October 2014. This agreement states that access to genetic resources can occur

only with prior informed consent by the provider country and a fair and equitable distribution of benefits

between the resource applicant and the resource provider must be specified through mutually agreed

terms. In addition, it requires the parties to adopt different measures to ensure that the genetic resources

used within their jurisdiction have been accessed in accordance with their national legislation (CBD,

2010). Thus, the NP is intended to be an instrument to deal with any case of misappropriation of

intellectual property (GIZ, 2016).

The Access and Benefit-Sharing (ABS) mechanism as part of the CBD treaty was intended as a response

to centuries of savage exploitation of biodiversity and lack of recognition of the ownership rights of

source countries (Heinrich and Hesketh, 2019). Quinine from Peruvian Cinchona species is a classic

example in this sense (Heinrich, 2013). Another example, also from Peru, is the resin of dragon’s blood

(Croton lechleri Müll.Arg.), used traditionally especially in the Amazon area, and sustained by a good

clinical and pharmacological evidence-base, but no benefits to local communities are known (Heinrich,

2013).

4
According to the NP “States have sovereign rights over the genetic resources found within their national

jurisdiction”, therefore each state can define the way of access to its natural resources when it comes to

research and development (Heinrich and Hesketh, 2019). Peru has been party to the NP since it has

entered into force, after having signed it on May 4, 2011. The process of ratification of the NP took

almost three years and was possible due to the joint effort of several governmental, academic and civil

society institutions, through the inter-institutional platform “Ad Hoc Group on Access and Benefit-

Sharing”, within the framework of the National Commission of Biological Diversity (CONADIB).

1.2 ABS, an opportunity for Peru

Peru is considered to be one of the most biodiverse countries in the world; 10% of all higher plants

species identified worldwide can be found within its territory (MINAM, 2010). Also, it is estimated that

the Peruvian Amazon holds more than 1000 plant species with commercial potential (FAO, 1994) 400 of

which are native plants with applications in pharmaceutical industry (Kámiche Zegarra, 2010).

Peruvian national sales of natural products derived from medicinal and aromatic plants exceed $400

million per year (UNCTAD, 2018). This is line with the global increasing demand for biotrade and

environment-friendly products with sales that boomed from $40 million in 2003 to more than $5 billion in

2016. Such growth offers huge opportunities for Peru, that could largely benefit from an efficient and

effective implementation of an Access and Benefit-Sharing (ABS) scheme (Silvestri, 2016) to achieve

some of its fundamental objectives. For example, it would be possible to: (a) slow down the loss of

biodiversity by distributing the benefits derived from the use of genetic resources with the countries that

provide them, who are generally rich in biodiversity but poor in financial resources (Silvestri, 2017; Godt,

2009); and (b) compensate indigenous and local communities for the use of their traditional knowledge in

5
relation to biodiversity, given that this information has been widely used for advancements in science, and

no reward for that has been granted (Aguilar, 2001).

Despite its richness in terms of indigenous traditional knowledge and biodiversity, Peru, like many other

countries, is struggling to update its administrative procedures and regulations in order to respond in a

timely manner to researchers and private companies that request formal access to genetic resources. For

national and international researchers, it is important to understand that any possibility of studying

Peruvian plants, and the possibility of creating patentable inventions, requires an authorization granted by

the competent Peruvian authorities. The implication for researchers is to consider whether or not to get

involved in such a procedure. The basic question is, does the Nagoya Protocol as it is currently

implemented in Peru promote research or block it?

The aim of this work is to describe the current level of implementation of the NP in Peru for performing

research on national genetic resources by presenting challenges and opportunities also related to the

global context, and to analyse its implications for the country and for the development of new products

based on its biodiversity.

2. Materials and Methods

A literature review on the application of the NP with a focus on Peru’s situation was performed. The

Access and Benefit-Sharing Clearing-House (ABSCH), which represent the main reference website to

learn about the application of the NP worldwide, was consulted. Major publications including peer

reviewed articles were analysed and discussed. Special consideration was given to the Interim National

Report on the Implementation of the Nagoya Protocol issued by the Peruvian Ministry of Environment

(MINAM) and published in the ABSCH website (MINAM, 2018a), as well as on other reports issued by

6
the different Peruvian authorities, including the recently published Sixth National Report to the

Convention on Biological Diversity 2014-2018 (MINAM, 2019a).

Moreover, a first-hand experience on the application of the protocol in Peru was undertaken by submitting

a request for access to the national authority responsible for the genetic resources related to wild

continental species, that is the National Forest and Wildlife Service (SERFOR). Direct field experience on

the implementation of NP/CBD of some of the authors of the article (FM, AH, MH, and VB) constitutes

an important part of the results presented in this research as does the experience of the authors in other

biodiverse regions (AH, MH, MP).

A review of the legal framework for the application of Nagoya Protocol in Peru was performed. The main

laws recorded and discussed are: a) Law N° 27811 on the Regime for the protection of collective

knowledge of indigenous peoples related to biological resources; b) S.D. Nº 003-2009-MINAM Supreme

Decree that approves the Regulation R.M. N° 087-2008-MINAM for Access to Genetic Resources; c)

Decision Nº 391 of Andean Community establishing the Common Regime on Access to Genetic

Resources; d) Decision Nº 486 of Andean Community Establishing the Common Industrial Property

Regime; e) Law Nº 28216 on the protection of access to Peruvian biological diversity and the collective

Knowledge of indigenous peoples.

3. Results & Discussion

From the website of the Access and Benefit-Sharing Clearing-House (ABSCH), as of January 2020, there

have been 1192 Internationally Recognized Certificates of Compliance (IRCCs) granted in 19 of the 123

countries which are party to the NP. The main countries of origin of the IRCCs are India (741), France

(233), Spain (55), Kenya (38), Vietnam (30), South Africa (29), and Panama (19). The other twelve

7
countries contribute 47 IRCCs. Latin American countries that have issued IRCCs include Mexico (8),

Uruguay (3), Guatemala (2) and the Dominican Republic (2). A more internationalized review involving

case studies from Latin American countries falls out of the scope of this study and could be a matter of

further investigation.

3.1 Implementation of NP in Peru

Peru’s ABS National Focal Point (NFP) is the Ministry of Environment (MINAM) that operates through 5

Competent National Authorities (CNA). Apart from the MINAM itself that is the governing body, among

the CNAs we find 3 Executive Authorities which are the institutions in charge of authorizing and

subscribing contracts for access to genetic resources and associated intangible components, and verify

compliance with the agreements. These are:

a) National Forest and Wildlife Service (SERFOR), responsible for granting access to genetic

resources related to wild continental species;

b) The National Institute of Agricultural Innovation (INIA), responsible for cultivated or

domesticated continental species;

c) Ministry of Production (PRODUCE) through the Vice Ministry of Fisheries and Aquaculture,

having jurisdiction over marine and hydrobiological species in continental waters;

The National Institute for the Defence of Free Competition and the Protection of Intellectual Property -

INDECOPI is responsible for protecting the Traditional Knowledge (TK) of indigenous peoples

associated with said genetic resources. In this sense, its activities are focused on the registration of TK,

registration of license of use agreements and monitoring of the rights of protection associated to TK.

National Law 27811 establishes the obligation to ask for the prior informed consent of the indigenous

8
people through their representative organizations when someone wants to access to collective knowledge,

and to subscribe a license contract for commercial and industrial purposes.

Peru’s checkpoints are located at the end of the access chain, these are:

a) The Directorate of Inventions and New Technologies (DIN) of INDECOPI, which has the

authority to resolve requests, among others, for invention patents, by verifying, if necessary, the

contract of access to the genetic resources and/or the license contract for the use of collective

knowledge of the indigenous peoples;

b) The National Commission Against Biopiracy (CNBio) that exercises control over illegal access to

genetic resources and associated traditional knowledge, through searches of granted patents and

patent applications in the main patent offices worldwide.

So far, Peru has not issued any ABS contracts for commercial purposes – though it has issued 6 IRCCs

for non-commercial research through two of the CNAs: INIA granted the very first Peru’s IRCC in

November 2017, while SERFOR granted the remaining 5 IRCCs, the first one in November 2018 and the

last one in November 2019. All the certificates are for non-commercial purposes, although one of these

has been signed by the INIA with a private company, Cosmo Ingredients, while the rest have been signed

with researchers supported by an academic institution. In the case of the access contract signed between

INIA and Cosmo Ingredients, the whole process, from initial application to the final access contract

signed, lasted around 24 months. This is in line with what stated by MINAM (2018b) which in its reports

indicates that the time for evaluating applications varies between three months to four years. In the case of

PRODUCE, to date no access contracts have been granted, however, there are applications pending for

9
more than two years (MINAM, 2019b). To date there are also 3 applications submitted to INIA currently

under revision that are expected to lead to new IRCCs in the next few months (MINAM, 2019b).

The request for access to genetic resources submitted in May 2019 as part of the present research is

reported by the officials of the competent national authority (SERFOR) as one of the very few requests

made by a foreign institution (University of Chieti, Italy); such information was acquired during an

informal dialogue with SERFOR competent personnel in charge of our ongoing application for IRCC.

3.2 IRCCs issued in Peru

Case 1. The National Institute of Agrarian Innovation - INIA stipulates an ABS contract with the private

company Cosmo Ingredients SAC on November 23, 2017. Certificate CCRI0001PER/INIA-2017 relates

to a contract for access to genetic resources for research purposes to obtain an extract of leaves of the

Peruvian pepper or molle (Schinus molle L), as a potential ingredient in cosmetics. This study does not

include documented traditional knowledge related to molle genetic resources. This certification marks a

milestone in the sustainable and legal use of the country's genetic diversity1. Date of expiry of the permit

is not indicated.

Case 2. SERFOR records an agreement with a researcher from the Peruvian Universidad Catolica Sedes

Sapientiae on November 19, 2018 for non-commercial use of "Samples of microorganisms from

traditional fermented beverages of Peru". Access Contract No. 001-2018-MINAGRI-

SERFOR/DGGSPFFS-DGSPF. No further information is available online. Date of expiry of the permit:

19 November 2021.

1
http://www.minam.gob.pe/notas-de-prensa/ministerio-del-ambiente-realizo-taller-para-promover-las-oportunidades-de-
negocio-en-el-uso-de-recursos-geneticos/
10
Case 3. On 19 January 2019, SERFOR records an agreement with a researcher from the Universidad

Peruana Cayetano Heredia related to the project: "In vitro antifungal activity of the ethanolic extract of

the barks of Iryanthera juruensis Warb., Virola calophylla Warb. and Vismia amazonica Ewan., against

Malassezia furfur and Malassezia globosa". This project seeks to determine in vitro antifungal activity of

the extract of the bark of some wild flora species, through tests of antifungal sensitivity against the

pathogenic fungi that cause Pitiriasis versicolor. This is an infectious disease that causes a

depigmentation of the skin and that mainly affects adolescents or young adults, in countries located in

tropical or subtropical regions. Access Contract N° 001-2019-MINAGRI-SERFOR/DGGSPFFS-

DGSPF2. Date of expiry of the permit: 16 August 2019.

Case 4. 17 May 2019, SERFOR records an agreement with Universidad Peruana Cayetano Heredia for

non-commercial research of 477 specimens of wild flora belonging to 77 families, Access Contract N °

003-2019-MINAGRI-SERFOR/DGGSPFFS-DGSPF. Date of expiry of the permit: 17 May 2029.

Case 5. 12 April 2019, SERFOR records an agreement with a researcher at the Natural History Museum

of the National University of San Marcos for the non-commercial investigation of a wide variety of flora

and fauna specimens, ABS Contract N° CTO-ARG-2019-002. Date of expiry of the permit: 12 April

2021.

Case 6. 11 November 2019, SERFOR records an agreement with a researcher from the Institute of

Systematic Botany of the New York Botanical Garden for the taxonomic, non-commercial study of 235

specimens corresponding to 20 genera of wild flora belonging to the Family Melastomataceae. Date of

expiry of the permit: 11 May 2021.

2
https://www.serfor.gob.pe/noticias/minagri-aprueba-proyecto-vinculado-al-acceso-a-los-recursos-geneticos-de-especies-de-
flora-silvestre
11
Based on the information of the access contracts signed by SERFOR and INIA, most of the contracts

signed include benefits aimed at the conservation of biological diversity, identifying the importance

related to its protection and sustainable use, and expanding knowledge around the species involved,

allowing them to be valued.

According to the Interim Report (MINAM, 2018a), so far the application of the NP has generated both

monetary benefits, with direct payment for collection and salary payment to experts for identification and

collection activities, as well as non-monetary benefits that are considered greater and include:

participation of national professionals in the process; the strengthening and development of the National

Support Institution or the provider institution; the transfer of scientific and technological knowledge to

national professionals; the putting in place of conditions for in-country research that contributes to the

conservation and sustainable use of biological diversity; and the strengthening of mechanisms for

knowledge and technology transfer (MINAM, 2018a).

3.3 Challenges and difficulties

Although access and benefit sharing in the use of genetic resources is one of the goals of the National

Biodiversity Strategy - EPANDB 2021, the recently published Sixth National Report to the Convention

on Biological Diversity (MINAM, 2019a) recognizes that progress has been made at an insufficient rate:

as of 2018, only 30% of the regulatory framework established with the Nagoya Protocol has been

implemented in Peru. In addition, researchers who have analysed Peru’s ABS system (Silvestri, 2016),

and other government reports (MINAM, 2018a), indicate that Peru faces several important challenges and

difficulties in relation to the subject of ABS. We can highlight the following:

12
a) Following the implementation of NP in Peru, researchers are asked specific information about

their research activities, including what they plan to do during a visit to a provider country and to

prepare a benefit-sharing plan. Researchers report several concerns (Kupferschmidt, 2018); one of

these is practical and has to do to the fact that this adds to their work a huge burden of regulations

to face. In the case of Peru, the procedure of access to genetic resources is complex and

bureaucratic. There is no adequate dissemination of the steps to follow and requirements for users

to be able to submit an application in the first place, which in fact discourages the negotiation of

ABS contracts (Silvestri, 2016). Also, once the application is received and processed, in some

cases issuing access authorizations demands up to two or four years (MINAM, 2018b). In the case

of the request for access submitted as part of the present research, the preliminary response of

SERFOR after three months of waiting is to propose several remarks and comments, which will

have to be amended in order to move ahead, thus implying additional paperwork.

b) There is weak monitoring and supervision regarding compliance with the terms and conditions of

access contracts (Silvestri, 2016). Although compliance measures and verification points have

been established in accordance with the provisions of the Nagoya Protocol, there is no control

over the legality of access to genetic resources and traditional knowledge associated with the use

of these when they come from any country other than Peru. Verification points are considered to

be insufficient in number (MINAM, 2018a). The current challenge is to establish additional

verification points that cover the stages of: i) research; ii) development; and iii)

commercialization. This could be achieved by appointing other interested and competent national

parties such as the National Council of Science, Technology and Technological Innovation

(CONCYTEC), the General Directorate of Environmental Health (DIGESA) and the Directorate

General of Medicines, Supplies and Drugs (DIGEMID).

13
c) Lack of personnel and budget dedicated to the implementation of the legal framework has been

observed (MINAM, 2018a). While the system has a total staff of 12 managers, 5 coordinators and

35 specialists, in almost all institutions the number of managers is greater than or equal to the

number of specialists. Only in the case of INDECOPI is there a pyramidal distribution of the staff

with a much larger number of specialists (26) over managers (2) (MINAM, 2018a). The

continuous rotation of managers and contact person within the national authorities is another issue

of concern for researchers (MINAM, 2018a). Another challenge reported is the need for more

training on ABS among the actors involved in the process: authorities, national and regional

officials, the scientific community, native communities and the general public.

d) It is considered necessary to promote the institutional co-ordination between the governing body

(MINAM), the CNAs, the National Support Institutions, the Checkpoints and other involved

actors, as well as strengthening their capacities for monitoring and supervision (MINAM, 2018a).

Being sectored authorities, the CNAs have shown difficulties in the interpretation of the

jurisdiction that corresponds to each institution in terms of certain aspects of the law and access

administration, as for example with the distribution of certain taxonomic groups among the CNAs

(microorganisms, wild relatives of a cultivated species, etc.). There is also poor co-ordination

between the authorities that grant access to genetic resources and the authorities that presides over

the protection of traditional knowledge.

e) The role of the "National Support Institution" seems to be distorted, being considered as a mere

controller; if this situation is not improved, valuable scientific collaborations in favour of local

scientific institutions will be lost (Silvestri, 2016).

14
f) The ambiguity of Peruvian regulations generates contrasts with what is indicated in the

international reference laws. An example is that Peruvian legislation on ABS has retroactive

effects, infringing the principle of legal certainty that should prevail in any contractual relationship

(Silvestri, 2016). During our first-hand experience by preparing a request for access to SERFOR,

we discover that another conflict with international laws, in this case Decision 391, is the fact that

Peru’s law includes an exemption for “research activities involving the use of non-timber natural

resources, to produce natural products (nutraceuticals and functional foods)”, which seems to offer

a huge chance to private companies to circumvent the ABS scheme. Because the category of

nutraceuticals is not regulated in Peru, the introduction of this very specific exemption seems to be

even more ambiguous and enigmatic. This could allow foreigner companies to register in their

countries Peruvian plant products as nutraceuticals without following Peruvian ABS scheme.

g) The greatest demand for genetic resources is focused on research, but we observe a gap between

the regular access to genetic resources that passes through the ABS system and the one that occurs

outside of it. According to MINAM (2018b) up to 2017, only 30% of the research and

development activities identified (86 out of 290) were passing through the ABS system.

h) A difficulty not exclusive to Peru concerns monetary ABS agreements. At least 5% of the gross

sales resulting from the commercialization of the products developed from the collective

knowledge must be given back to the provider organization. To this must be added 10% to the

Fund for the Development of Indigenous Peoples, whose initial objective was to strengthen

indigenous organizations, achieve its development, and safeguard its traditions and knowledge.

This measure is so far considered ineffective (MINAM, 2019a). First, the Fund, has not yet been

15
 created. Secondly, since the promulgation of Law 27811, no agreement for the use of traditional or

collective knowledge has been signed; and no request has been registered (MINAM, 2018a). We

can find two explanations: from the user side, that the monetary benefits are considered too high

by private companies; and from the provider side, that the indigenous and local communities have

limited knowledge of the legal framework and no control over an illegal access by national and

foreign users. Also, reports consider that there is still no clear identification of those populations

that possess traditional knowledge associated with biological resources, whose rights have not

been covered by Law 27811 (MINAM, 2018a); the development of community protocols is still in

an incipient state.

i) The use of patent protection for intellectual property in the field of ethnopharmacology/natural

product research has often received negative comments (Heinrich and Hesketh, 2019).

Researchers suggest that the real issue is not the patenting of natural products, but the lack of

engagement with the provider countries (Heinrich and Hesketh, 2019).

3.4 The cart before the horse; a company’s perspective

If we approach the Nagoya Protocol from the companies’ perspective, it could be considered premature to

undertake such an apparently complicated system before even knowing if the conditions exist for

investing in the research and development of a new product. A practical example may illustrate this

perspective. Indena is a European based, research driven company, devoted to the research, production

and sales of botanical derivatives for use, mainly, in the medicinal, health food and cosmetics markets.

Ethnopharmacology, the scientific study of ethnic groups and their use of drugs, mainly based on

botanical remedies (Hesketh, 2015), offers a strong rationale for the development of innovative modern

botanical derivatives. This way of exploring old remedies with a modern and scientific approach is

16
strongly linked to a possible involvement of local traditional knowledge. Indena is following the evolution

of the local rules concerning access and benefit sharing and develops internal procedures for the

compliance with the European regulation 511/2014 (“on compliance measures for users from the Nagoya

Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from

their Utilization in the Union”). Even though one of the main concerns of NP’s parties is the defence of

provider countries biodiversity, Indena’s approach is strongly devoted to the sustainability of its genetic

resources supply chain; this is a common concern in the field of natural product research and

development, as pointed out by the recently coined dedicated term “eco-pharmacognosy” (Cordell, 2011,

2014a, 2014b). In the event that a research project has a positive outcome and a new product is launched,

the first burden for a company is being able to source enough quantities of the relevant biomass to satisfy

market needs in the long term. Thus, benefit sharing, including financial support to local providers,

becomes highly advisable, keeping in mind the target of supply chain sustainability. Other important

points in managing research projects complying with NP principles are the certainty of local ABS rules;

and a reasonable timing to get PIC and MAT. These are also important issues when a company needs to

comply with European regulation 511/2014.

3.5 Digital sequence information and pathogens

A current topic of discussion around NP is the possibility to include “digital sequence information” in an

international agreement against misappropriation of intellectual property. For example, researchers might

be obliged to ask for permission before using publicly available gene sequences obtained from plants or

animals originating there. This could stifle research, hamper the fight against disease outbreaks, and even

jeopardize food safety.

17
Most of the NP parties consider human pathogens, such as bacteria, fungi and viruses as genetic resources

that fall under the scope of the Protocol (Manheim, 2019), given that these are defined as “any material of

plant, animal, microbial or other origin containing functional units of heredity”. As a result, the use of

pathogens for public health purposes is subject to the ABS requirements and procedures of individual

countries. A concern expressed by the US State Department is that the development of vaccines and other

medical products to address urgent global health threats could be substantially delayed by the need for

ABS agreements between manufacturers and provider countries, given that the negotiation of an ABS

agreement is often a long and challenging process (US State Department, 2019). This problem may be

exacerbated by the position of many of the Protocol parties that consider the term “genetic resources” to

include “digital sequence information” of pathogens. In light of the potential impacts that the Protocol

may have on the development of vaccines and other medical products, WHO is considering adoption of

an alternative ABS system to govern the sharing of pathogen genetic materials (US State Department,

2019).

In the face of the possible appearance of emergency health situations (epidemics or pandemics), Peru

believes that mechanisms should be activated to facilitate access to genetic resources that can be used to

prepare vaccines, diagnostic kits, medicines, etc. (MINAM, 2018a). However, considering that these are

currently developed by countries with a more advanced biotechnological sector, provider countries such

as Peru are at risk, not only of becoming mere suppliers of genetic resources for human pathogens, but

also to be customers of these biological medicinal products prepared through the use of the very same

genetic resources whose access has been granted by Peru. Considering this, the Interim National Report

on the Implementation of the Nagoya Protocol proposes establishing speed-up procedures not only for

granting access authorizations, but also for the fair and equitable participation in the derived benefits,

without ignoring the fulfilment of requirements such as the prior informed consent (PIC) and the mutually

18
agreed terms (MAT) (MINAM, 2018a). As part of the benefits to be negotiated for the use of genetic

resources from pathogens, the Interim Report suggests establishing cooperation mechanisms between the

countries with the highest technological development and the national health sector, in order to create,

develop and strengthen local human resources, as well as institutional and infrastructure capacities, in the

perspective that in the near future, Peru could be able to manufacture its own vaccines and cease to be

only a provider of genetic resources (MINAM, 2018a).

3.6 Reactions and solutions proposed by the Peruvian government

In 2002 INDECOPI summoned a group of institutions to perform a technical analysis of some complaints

regarding cases of misappropriation or biopiracy, specifically referring to maca (Lepidium meyenii

Walp.). This so-called “Grupo de la Maca” (Maca Group) determined that biopiracy regarding maca was

not an isolated case but part of a global trend (INDECOPI, 2003). The Group demonstrated the problems

faced by mega-diverse countries like Peru in relation to the international patent system (GIZ, 2016) before

the World Intellectual Property Organization (WIPO) Intergovernmental Committee on Intellectual

Property and Genetic Resources, Traditional Knowledge and Folklore (IGC). This was the first step

toward the creation of the National Commission Against Biopiracy (CNBio) whose monitoring work has

been widely recognized nationally and internationally. During 2018 Peru’s CNBio won 45 cases of

misappropriation of intellectual property worldwide regarding the misuse of traditional knowledge linked

to Peruvian biological resources (SPDA, 2019). Among the most frequent cases identified in 2018, we

find several related to the use of dragon’s blood (Croton lechleri Müll.Arg.) with 26, maca with 24, and

sacha inchi (Plukenetia volubilis L.) with 8, among others. These are some of the 69 biological resources

of Peruvian origin that the CNBio has put among its priorities to carry out a permanent monitoring on

patenting (INDECOPI, 2018). In the case of maca, patent cases are filed predominantly by a single

country, China. The same seems to be happening with sacha inchi. In 2017, CNBio detected two patent

19
applications filed by the China Eucalypt Research Center with the State Intellectual Property Office

(SIPO) of China and started an investigation on the applicant for information on the source of access to

the genetic resource. “Peru should consider the possibility of participating much more actively in the

research and development processes relating to plants and biological materials”, as affirmed in the 2003

Peru WIPO IGC submission (INDECOPI, 2003).

April 2018 marked the beginning of the project "Effective Implementation of the Access and Benefit

Sharing and Traditional Knowledge Regime in Peru in accordance with the Nagoya Protocol" funded by

the Global Environmental Facility (GEF) and led by the national Peruvian authorities involved in the NP3.

The objective of this project is "to put into practice the Nagoya Protocol for access to genetic resources",

as an opportunity to strengthen the national framework and reduce illegal access. Many of the previously

reported weaknesses, challenges and difficulties should be addressed by this project, which seeks to: (i)

establish an efficient functioning of the ABS mechanisms in accordance with the NP, (ii) strengthen the

capacity of the various stakeholders in relation to access to genetic resources and traditional knowledge,

(iii) implement pilot projects and initiatives on ABS that contribute to the sustainable use of Peru´s

biodiversity, (iv) train public workers to make correct decisions when evaluating the requests for access

(MINAM, 2018a). Additionally, to respond to the lack of information about the NP among knowledge-

providing communities, a strategy is being implemented to raise awareness of the ABS scheme and the

NP, which aims to disseminate among indigenous peoples the norms and mechanisms on protection of

traditional knowledge, and develop a capacity-building program for indigenous peoples and communities

in negotiation on traditional knowledge.

3
https://unctad.org/meetings/en/Presentation/ditc-ted-12092018-BioTrade-IV-Noejovich.pdf
20
In addition, a proposal from MINAM to update the regulations for access to genetic resources and their

derivatives is currently in its final stretch (MINAM, 2019b); the new law was initially expected to be

approved by the end of 2019 but, at the time the present manuscript (submitted in 02-2020), has not yet

been issued. Among the notable changes of this new proposal we find the elimination of the exemption on

nutraceuticals, given that the same government authorities seem to be aware of the obvious contradiction

that this exclusion generates. Other changes include the addition of an exemption for basic research

related to the identification, delimitation and classification of species for taxonomic, systematic,

phytogeographic purposes that do not have any commercial implication (MINAM, 2019b). Such studies

will go through a simpler procedure as a research authorization that is already being applied in the case of

ethnobotanical research. The general objective of this new law is to facilitate research and mark a clear

difference between access to genetic resources for non-commercial research, on one hand, and for

commercial purposes, on the other hand. The new proposal also aims at giving greater importance to the

National Support Institution, specifying its role in assisting the foreign applicant in access activities, as

well as its rights and obligations.

4. Conclusions

The present research shows that the current implementation of the NP inhibit scientific research in Peru

and the development of new commercial products based on Peruvian traditional knowledge and genetic

resources; sadly, it seems that adherence to the NP is costing dear to Peru, which is experiencing a sort of

paralysis in research and development activities on its genetic resources -of which the country is

extremely rich- while other neighbouring non-signatory countries are advancing at a rapid pace. This

highlights how the application of complex rules, although inspired by ethically correct principles and

marked by good intentions, could be counter-productive, especially in developing countries or similar, at

21
least in this preliminary phase. There needs to be active consultation with all stakeholders, both nationally

and internationally.

Some of the difficulties observed concern with the degree of effective implementation of the ABS system,

the lack of clarity of the application process, the slow response and the wide gap between this formal

system and what occurs informally outside of it. Although the highest demand for access is concentrated

on research, the complexity of the procedure to apply the NP in Peru seems to penalize international

research collaborations, rather than facilitating it as suggested by its objectives. This appears to confirm

what has been observed in other studies (Deplazes-Zemp et al., 2018). The ineffective application of the

NP in Peru could also lead companies and researchers to move their interests to neighbouring countries

that have a similar biodiversity and a less demanding regulatory framework, such as Brazil. A further

hurdle can often be the reluctance to embrace intellectual property rights, which hinders the essential open

dialogue and cooperation between commercial partners and biodiversity-rich countries such as Peru

(Heinrich and Hesketh, 2019).

Experience facilitates the process. Peru, like many other countries, only recently has been accumulating

some experience on this topic, as evidenced by the fact that the IRCC certificates issued so far are

concentrated between the end of 2018 and 2019, therefore in very recent times. It took almost 5 years for

the NP to start being applied in Peru. The challenge now is to improve the process. In addition, it can be

observed that most of the researchers who have obtained the IRCCs certificates had participated directly,

or indirectly through their academic institutions, in previous processes of access to genetic resources,

under the national legal framework pre-NP. The hope is that in the future this ability will not be limited to

a handful of researchers, but that the process will become more accessible to other researchers who can

provide new scientific knowledge and/or technologies. Currently, researchers might also consider waiting

22
until the approval of the new law proposed by MINAM (2019b) instead of keep trying to obtain access

under the current system.

Overall, to achieve a successful implementation of the Nagoya Protocol, an ABS framework should

encourage international partnerships. The mechanism should be based on mutual trust; involve all

stakeholders; and include clear and straightforward access requirements. Minimum royalty figures should

be avoided; instead local and foreign partners should be free to negotiate mutually acceptable terms. In

this way, open dialogue can be encouraged, which can lead to a result that is beneficial for all parties. An

ideal application of the Nagoya Protocol could also result in the promotion of the use of genetic resources

for the purpose of innovation and biotechnological development according to the needs of the country and

one concrete result could be the development of national laboratories and research centres in innovation

and biotechnology.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or

not-for-profit sectors.

23
References

Aguilar, G., 2001. Access to genetic resources and protection of traditional knowledge in the territories of

indigenous peoples. Environmental Science & Policy 4 (4-5), 241-256. DOI:

http://dx.doi.org/10.1016/S1462-9011(01)00028-4

CBD, 1992. Text of the Convention on Biological Diversity, Secretariat of the Convention on Biological

Diversity, Montreal. http://www.cbd.int/convention/text/default.shtml (accessed 30 January 2020).

CBD, 2010. Text of the Nagoya Protocol, Secretariat of the Convention on Biological Diversity,

Montreal. http://www.cbd.int/abs/text/default.shtml (accessed 30 January 2020).

Cordell, G.A., 2011. Sustainable medicines and global health care. Planta Medica 77, 1129–1138.

Cordell, G.A., 2014a. Ecopharmacognosy: exploring the chemical and biological potential of nature for

human health. Biology, Medicine, & Natural Product Chemistry 3 (1), 1-14.

Cordell, G.A., 2014b. Ecopharmacognosy and the globalization of traditional medicine. In:

Pushpangadan, P., George, P.V. (Eds.), Proceedings of the 7th International Symposium of the

International Society for the Development of Natural Products. Noida, Delhi, India. Daya Publishers,

New Delhi, India.

24
Deplazes-Zemp, A., Abiven, S., Schaber, P., Schaepman, M., Schaepman-Strub, G., Schmid, B., Shimizu,

K., Altermatt, F., 2018. The Nagoya Protocol could backfire on the Global South. Nature Ecology &

Evolution 2 (6), 917–919. doi:10.1038/s41559-018-0561-z

FAO, 1994. Consulta de expertos sobre productos forestales no madereros para América Latina y el

Caribe. FAO Serie Forestal No.1. http://www.fao.org/docrep/t2354s/t2354s15.htm (accessed 30 January

2020)

GIZ, 2016. Las relaciones entre las Herramientas de la Propiedad Intelectual, los Conocimientos

Tradicionales y Recursos Genéticos, en el contexto de la aplicación del Protocolo de Nagoya: Alcances y

Aproximaciones.

https://www.giz.de/en/downloads/Relacion_de_herramientas_de_PI_GR_CT_04_final.pdf (accessed 30

January 2020).

Godt, C., 2009. Enforcement of Benefit- Sharing Duties in User Countries, in: Genetic Resources,

Traditional Knowledge & The Law. In Kamau, E.C., Winter, G. (Eds.), Solutions for Access and Benefit

Sharing. Earthscan, London and Sterling, pp. 419-438.

Heinrich, M., 2013. Ethnopharmacology and drug development, in: Reedijk, J. (Ed.), Elsevier Reference

Module in Chemistry, Molecular Sciences and Chemical Engineering. Waltham, MA: Elsevier.

https://doi.org/10.1016/B978-0-12-409547-2.

25
Heinrich, M., Hesketh, A., 2019. 25 years after the ‘Rio Convention’ - Lessons learned in the context of

sustainable development and protecting indigenous and local knowledge. Phytomedicine 53, 332–343.

doi: 10.1016/j.phymed.2018.04.061

Hesketh, A., 2015. Ethnopharmacology and Intellectual Property Rights, in: Heinrich, M., Jäger, A.K.

(Eds), Ethnopharmacology. Chichester: Wiley & Sons Publ. doi:10.1002/9781118930717.ch9

INDECOPI, 2003. Patentes referidas al Lepidium meyenii (maca): Respuestas del Perú.

http://repositorio.indecopi.gob.pe/bitstream/handle/11724/4445/1345_SPI_Informe_final_Patentes_Lepidi

um_meyenii_Maca.pdf?sequence=1&isAllowed=y (accessed 30 January 2020).

INDECOPI, 2018. Balance 2017: Comisión Nacional contra la Biopiratería del Indecopi tramita

oposiciones a 11 casos de biopiratería relacionados a productos genéticos peruanos.

https://www.indecopi.gob.pe/inicio/-/asset_publisher/ZxXrtRdgbv1r/content/balance-2017-comision-

nacional-contra-la-biopirateria-del-indecopi-tramita-oposiciones-a-11-casos-de-biopirateria-relacionados-

a-productos-geneticos-p? (accessed 30 January 2020).

Kámiche Zegarra, J., 2010. Resumen Nacional Ambiental Perú 2010. [s.l.]: United Nations Environment

Programme. 100 pp.

Manheim, B., 2019. The Potential Impacts of the Nagoya Protocol on Global Public Health Research.

https://www.wilmerhale.com/en/insights/client-alerts/20190619-the-potential-impacts-of-the-nagoya-

protocol-on-global-public-health-research (accessed 30 January 2020).

26
MINAM, 2010. El Perú y el Cambio Climático. Segunda Comunicación Nacional del Perú a la

Convención Marco de las Naciones Unidas sobre el Cambio Climático. 200 p. http://unfccc.int/

resource/docs/natc/pernc2s.pdf (accessed 30 January 2020).

MINAM, 2018a. Informe Nacional Provisional sobre la Implementación del Protocolo de Nagoya

(Octubre 2014 – Septiembre 2017). https://absch.cbd.int/pdf/documents/absNationalReport/ABSCH-NR-

PE-238684/2 (accessed 30 January 2020).

MINAM, 2018b. Diagnóstico de la gestión de las autorizaciones de acceso a recursos genéticos con fines

de investigación y uso comercial otorgadas Periodo 2008-2017.

MINAM, 2019a. Sexto informe nacional sobre diversidad biológica. Informe de gestión.

https://cdn.www.gob.pe/uploads/document/file/360830/Informe_de_Gestion_final.pdf (accessed 30

January 2020).

MINAM, 2019b. Resolución Ministerial Nº205-2019-MINAM.

https://cdn.www.gob.pe/uploads/document/file/340780/RM_N__205-2019.pdf (accessed 30 January

2020).

Silvestri, L., 2016. Conservación de la diversidad genética en el Perú: desafíos en la implementación del

régimen de acceso a recursos genéticos y distribución de beneficios. Revista Peruana de Biología 23 (1),

73-79. https://dx.doi.org/10.15381/rpb.v23i1.11837

27
Silvestri, L., 2017. Protocolo de Nagoya: desafíos originados a partir de un texto complejo, ambiguo y

controversial. Anuario Mexicano de Derecho Internacional 17, 697-716.

SPDA, 2019. Indecopi: Perú ganó 45 casos de biopiratería en el mundo durante 2018.

https://www.actualidadambiental.pe/indecopi-peru-gano-45-casos-de-biopirateria-en-el-mundo-durante-

2018/ (accessed 30 January 2020).

UNCTAD, 2016. 20 years of BioTrade: Connecting people, the planet and markets.

https://unctad.org/en/PublicationsLibrary/ditctedmisc2016d2_en.pdf (accessed 30 January 2020).

UNCTAD, 2017. BioTrade and Access and Benefit Sharing: From concept to practice. A handbook for

policymakers and regulators. https://unctad.org/en/PublicationsLibrary/ditcted2017d6_en.pdf (accessed

30 January 2020).

UNCTAD, 2018. Peru's BioTrade sales reach new high but challenges to growth remain.

https://unctad.org/en/pages/newsdetails.aspx?OriginalVersionID=1858 (accessed 30 January 2020).

US State Department, 2019. Notice and Request for Comments on the Implications of Access and

Benefit-Sharing (ABS) Regimes on Global Health and Biomedical Research.

https://www.federalregister.gov/documents/2019/06/10/2019-12150/notice-and-request-for-comments-

on-the-implications-of-access-and-benefit-sharing-abs-regimes-on (accessed 30 January 2020).

28